FDA Approves Technivie for Hepatitis C
For people with chronic hepatitis C genotype 4
FRIDAY, July 24, 2015 (HealthDay News) -- Technivie (ombitasvir, paritaprevir and ritonavir) has been approved by the U.S. Food and Drug Administration, in tandem with ribavirin, to treat hepatitis C genotype 4 infection among people without cirrhosis and without scarring.
Technivie is the first drug to be sanctioned to treat genotype 4 hepatitis C infection without requiring co-use of the drug interferon, the agency said Friday in a news release.
The Technivie/ribavirin combination was evaluated in a clinical study involving 135 people. Of the participants who received Technivie with ribavirin, 100 percent achieved a sustained virologic response, while 91 percent of those who received Technivie without ribavirin achieved a sustained virologic response. The most commonly reported side effects included fatigue, asthenia, nausea, insomnia, pruritus, and other skin reactions.
Technivie's label includes a warning of the possibility of elevated liver enzymes, a result that occurred most often among women who took contraceptives containing ethinyl estradiol. Such contraceptives should be discontinued before these women take Technivie, the FDA advised.
Technivie is marketed by AbbVie, based in North Chicago.